(227 days)
The intended use of the AXIAMED Trans-Sacral Spinal Access Device is for minimally invasive access to the anterior portion of the lower spine for the purpose of assisting in the treatment of decompression of the lumbar disc or the performance of lumbar discectomy.
The AXIAMED Trans-Sacral Spinal Access Device is for minimally invasive access to the anterior lower spine and consists of the following components:
Blunt Trocar with Trocar Guide Stylet Threaded Guide Dilator Sheath, Small Dilator Sheath, Large Threaded Guide Sheath, 3mm Threaded Guide Sheath, 4mm Drill Bit, 3 mm Drill Bit, 4mm Delivery Cannula with blunt stylet
The provided document is a 510(k) summary for the AXIAMED Trans-Sacral Spinal Access Device, which is a regulatory submission to the FDA. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document states that the FDA reviewed the premarket notification and determined the device is "substantially equivalent" to predicate devices marketed prior to May 28, 1976. This determination is based on a comparison to existing devices, not on specific performance criteria met through a dedicated study with ground truth, expert review, or statistical analysis (such as sample size, effect size, or MRMC studies).
Therefore, I cannot provide the requested information from the given text. The 510(k) summary focuses on device description, predicate devices, and the FDA's regulatory determination of substantial equivalence. It does not include the detailed study design and acceptance criteria typically found in clinical trial reports or validation studies.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.